Some examples of diagnostic, life science research and drug discovery reagents require preparation prior to use. For instance, reagents may require measuring a diluent (or solution) and using the diluent to rehydrate a dry reagent. In other examples, preparation of the reagent requires measuring and mixing of a sample solution (e.g., a patient biological sample; an environmental sample such as, water or soil; an agricultural sample such as food and the like) with a reagent in a dried or liquid form. In still other examples, preparation of the reagent requires mixing of two or more liquid components, such as a reagent and another solution.
Manufacturers of diagnostic, life science research and drug discovery reagents use precision and standardized procedures in order to produce high quality reagents. These reagents are often prepared at their point of use. The quality of the reagents (e.g., the precise amount of reagent solution, the purity of the reagent solution and the like) is easily compromised at the point of use because of errors in preparation procedures that are used by personnel responsible for preparing the reagent. For instance, the reagent is handled in an unclean environment having contaminants (e.g., a humid atmosphere; a biologically active environment contaminated with microorganisms, DNA, RNA, ATP and the like; a chemically active environment, and the like), the wrong amount of solution is used, the wrong solution is used, and the like. In other examples, the reagent and solution or diluent are not allowed to mix thoroughly. In still other examples, the reagent solution is dispensed from a device but fails to deliver the full specified amount of reagent solution as a result of operator error or device performance (e.g., a portion of the solution is left within the device).
Where lyophilized reagents (e.g., dried or freeze-dried reagents) are used, unwanted exposure to contaminants including, but not limited to, moisture or moisture vapor during storage and prior to reconstitution may contaminate or compromise the stability of the lyophilized reagent. Compromising the reagent decreases its ability to rapidly rehydrate thereby creating difficulties in preparing a reagent at the proper concentration. Additionally, compromising the reagent from a dry state (where biological and chemical activities of the reagent are arrested) may reactivate the reagent and allow it to prematurely break down thereby decreasing the effectiveness of the reagent.
Even small errors in preparation leading to an improperly prepared reagent (e.g., mis-measuring of a solution, failure to fully reconstitute the reagent or diluting the reagent and the like) may have undesirable consequences, including, but not limited to, false positives, inaccurate diagnoses leading to inaccurate or inappropriate treatments, and false negatives (undetected diagnoses resulting in no treatment where treatment is needed).